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Neuren Pharmaceuticals Limited ( (AU:NEU) ) has issued an update.
Neuren Pharmaceuticals announced that the FDA has granted a Type C Meeting to discuss the primary efficacy endpoints for its Phase 3 clinical trial program of NNZ-2591, aimed at treating Phelan-McDermid syndrome. This step follows positive outcomes from a prior Type B Meeting, marking progress toward the commencement of the first-ever Phase 3 trial for this condition in children, reflecting Neuren’s strategic advancement in addressing unmet medical needs in neurodevelopmental disorders.
More about Neuren Pharmaceuticals Limited
Neuren Pharmaceuticals Limited is engaged in developing drug therapies for serious neurological disorders that emerge in early childhood, particularly those with no or limited treatment options. The company focuses on rare and severe diseases, with their programs receiving ‘orphan drug’ designation in the US. Their portfolio includes DAYBUE™ (trofinetide), approved for Rett syndrome, and NNZ-2591, in development for multiple neurodevelopmental disorders.
YTD Price Performance: 10.76%
Average Trading Volume: 1,200
Technical Sentiment Consensus Rating: Hold
Current Market Cap: $1.12B
Learn more about NEU stock on TipRanks’ Stock Analysis page.
